An Exploratory Clinical Study of the Efficiency and Safety of TH027 in the Treatment of Relapsed/Refractory Solid Tumors

NCT ID: NCT06951425

Last Updated: 2025-05-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2028-11-30

Brief Summary

This is a Phase l, Open-Label, Dose-escalation Study to Evaluate the Safety, Tolerabilityand Antitumor Activity of TH027 CAR-T Cell lnjection (TH-CART-027) in Subjects With Relapsed or Refractory Solid Tumors.

Conditions

Solid Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment of B7H3+ solid tumors

Intraperitoneal Infusion for Ovarian Cancer and Peritoneal Metastatic Tumors; Intravenous Infusion for Other Types of Solid Tumors

Group Type: EXPERIMENTAL

TH-CART-027

Intervention Type: DRUG

3+3 dose escalation design: Dose Level 1: 0.3×10\^6 CAR+ T cells /kg; Dose Level 2: 1.0×10\^6 CAR+ T cells /kg; Dose Level 3: 3.0×10\^6 CAR+ T cells /kg

Interventions

TH-CART-027

3+3 dose escalation design: Dose Level 1: 0.3×10\^6 CAR+ T cells /kg; Dose Level 2: 1.0×10\^6 CAR+ T cells /kg; Dose Level 3: 3.0×10\^6 CAR+ T cells /kg

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 1.The patients were aged from 18 to 75 years old (including the cut-off value), and the gender was not limited;
• 2.The expected survival time was more than 12 weeks;
• 3.ECOG score was 0-2;
• 4.One of the following tumor types was confirmed by pathology: osteosarcoma, neuroblastoma, gastric cancer or lung cancer, and the positive rate of CD276 expression in tumor tissue was more than 30% by immunohistochemistry;
• 5.Patients with ineffective standard treatment methods (such as postoperative recurrence, chemotherapy, radiotherapy, and progression after targeted drugs);
• 6.According to RECIST 1.1, there was at least one measurable lesion (the longest diameter of solid lesion >=10 mm, or the short diameter of lymph node lesion >=15 mm);
• 7.The function of main organs was normal (white blood cell count >= 3 × 10^9 / L, neutrophil count >= 1.5 × 10^9 / L, hemoglobin >= 8.5g/dl, platelet count >= 80 × 10^9 / L and lymphocyte count at 1 × 10^9 / L (including) ~ 4 × 10^9 / L (inclusive);
• 8.The liver and kidney function and cardiopulmonary function meet the following requirements:
• Urea and serum creatinine <= 1.5 × ULN；
• Left ventricular ejection fraction >= 50%;
• Baseline oxygen saturation >= 94%;
• Total bilirubin <= 1.5 × ULN； ALT and AST <= 2.5 × ULN；
• 9.The patient or legal representative can fully understand the significance and risk of this trial and has signed the informed consent.

Exclusion Criteria

• 1.Patients with history of immune deficiency or autoimmune diseases (including but not limited to rheumatoid arthritis, systemic lupus erythematosus, vasculitis, multiple sclerosis, insulin-dependent diabetes, etc.); Patients with graft-versus-host disease (GVHD) or need immunosuppressive agents;
• 2.There was a history of other second malignancies in 5 years before screening;
• 3.Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) were positive, and the peripheral blood HBV DNA titer was not within the normal reference value; HCV antibody and HCV RNA in peripheral blood were positive; HIV antibody positive patients; Syphilis was positive;
• 4.Severe heart disease: including but not limited to unstable angina pectoris, myocardial infarction (within 6 months before screening), congestive heart failure (NYHA classification >= III), severe arrhythmia;
• 5.Unstable systemic diseases judged by researchers: including but not limited to severe liver, kidney or metabolic diseases requiring drug treatment;
• 6.Within 7 days before screening, there were active or uncontrollable infections requiring systemic treatment (except mild urogenital infection and upper respiratory tract infection);
• 7.Pregnant or lactating women, female subjects who plan to conceive within one year after cell transfusion, or male subjects whose partners plan to conceive within one year after cell transfusion;
• 8.Patients who had received CAR-T therapy or other gene modified cell therapy before screening;
• 9.The subjects who were receiving systemic steroid treatment within 7 days before the screening or who needed long-term systemic steroid treatment (except inhalation or local use) were determined by the researchers;
• 10.The ascites increased gradually after 2 weeks of conservative treatment (such as diuresis, sodium restriction, excluding ascites drainage);
• 11.According to the judgment of the researcher, it does not conform to the situation of cell preparation;
• 12.Other researchers think that it is not suitable for inclusion.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ThinkingBiomed

UNKNOWN

Sponsor Role: collaborator

Shanghai Tongji Hospital, Tongji University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Aibin Liang

Professor, Chief Physician, Vice President of Tongji Hospital, Tongji University School of Medicine etc.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shanghai Tongji Hospital, Tongji University School of Medicine

Shanghai, , China

Countries

China

Central Contacts

Liying Chen

Role: CONTACT

lab7182@tongji.edu.cn

+86 15618670468

Facility Contacts

Liying Chen

Role: primary

lab7182@tongji.edu.cn

+8615618670468

Other Identifiers

TH027-ST001

Identifier Type: -

Identifier Source: org_study_id